FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
K Number: K041824
·
Decision Jan 7, 2005
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
2
Review Days
185
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Basic Information
- Device Name
- X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM
- K Number
- K041824
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Future Medical Systems, SA
- Date Received
- July 6, 2004
- Decision Date
- January 7, 2005
- Product Code
- HRX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
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Other Clearances by Future Medical Systems, SA
| K Number | Device Name | ||
|---|---|---|---|
| K024185 | BIODHOC | Jan 15, 2004 | Substantially Equivalent |